Hernia stapler

ABSTRACT

A surgical stapler for use during an open hernia repair comprises an elongated shaft having a handle at its proximal end and a downwardly disposed staple discharge head at its distal end. A squeeze trigger on the handle is operable to cause a supply of staples to be selectively discharged from the port. One or more mesh manipulators are provided on the head and serve to assist in positioning or otherwise manipulating surgical mesh prior to fixation with the staples. In one form, the stapler includes a chamfered portion, a cantilevered portion, and a retention lip to prevent multiple staples from deploying after a single pull of the trigger. Further, in this form, the stapler prevents incomplete staple formation if side load forces are applied during insertion of a staple in tissue thereby reducing waste of staples.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.13/425,590 filed Mar. 21, 2012, which is a continuation-in-part of U.S.patent application Ser. No. 12/880,492 filed Sep. 13, 2010, now U.S.Pat. No. 8,827,135, which is a continuation of PCT/US2009/037119 filedMar. 13, 2009, which claims the benefit of U.S. Provisional ApplicationSer. No. 61/036,644 filed Mar. 14, 2008, the disclosures of which arehereby incorporated by reference.

BACKGROUND

This application is generally related to means for applying surgicalstaples to fasten a surgical mesh. More specifically, but notexclusively, it is related to a surgical stapler having a distalmanipulator for positioning a surgical mesh prior to application of thestaples.

Chapters 14 and 23 of “Lichtenstein Tension-Free Hernioplasty For TheRepair of Primary and Recurrent Inguinal Hernias”, pages 149-157 of “TheTransabdominal Preperitoneal Laparoscopic Herniorrhaphy”, and pages256-268 of Nyhus and Condon's Hernia, Fifth Edition, edited by Robert J.Fitzgibbons and A. Gerson Greenburg, published by Lippincott Williams &Wilkins, Philadelphia, 2002, describe some procedures for repair ofinguinal hernias. A sheet of monofilamented polypropylene mesh ismentioned as a material suitable for use in such procedures. Aftershaping and placement of the mesh in the repair site, it is sutured toadjacent tissue.

While suturing is a long-standing practice for securing the mesh, somestapling is frequently favored because of the speed and relative ease ofuse. At some locations desired for attachment of the mesh to tissue,stapling is possible, but holding and stapling the mesh to tissue atsome other locations where attachment is desired can be challenging, ifnot impossible, for one pair of hands. Improvement is needed.

SUMMARY

The present invention provides systems and techniques for applyingsurgical staples and for using staples to hold a surgical mesh, forexample during an inguinal hernia repair. The systems and techniques mayalso be applied during ventral/incisional hernia repair, used for skinclosure, or used in other surgical procedures as would occur to theskilled artisan. While the actual nature of the invention covered hereincan only be determined with reference to the claims appended hereto,certain aspects of the invention that are characteristic of theembodiments disclosed herein are described briefly as follows.

According to one aspect, a surgical stapler includes an elongated shafthaving a handle at its proximal end and a downwardly disposed dischargehead at its distal end. The stapler also includes an angled magazine ofstaples mounted between the discharge head and the shaft and a pusherplate disposed in the discharge head. In one form, the pusher plateincludes a pair of forming fingers adapted to retain a single staplefrom the magazine of staples between the forming fingers. Moreover, inanother form, each of the pair of forming fingers includes a retentionlip. Typically, the retention lip has a height that corresponds to athickness of the single staple. In yet another form, each of the pair offorming fingers includes an inner edge, an outer edge, and a staplecontact portion that spans between the inner and outer edges, whereinthe inner edge and the staple contact portion include a retention lip.Each of the pair of forming fingers may also include a chamfered portionadapted to engage only the single staple from the magazine of staples.Some embodiments include an anvil plate positioned in the discharge headadjacent the pusher plate wherein the anvil plate has a step with aheight that corresponds to about the thickness of the single staple andthe step is adapted to position the single staple under the chamferedportion when the pusher plate passes over the anvil plate. The pair offorming fingers can be adapted to slide adjacent the step.

According to another aspect, a novel surgical stapler includes anelongated shaft having a handle at its proximal end and a downwardlydisposed staple discharge head at its distal end, wherein the handle isoperable to cause a supply of staples to be selectively discharged fromthe head. The stapler includes a pusher plate positioned in the stapledischarge head wherein the pusher plate includes a retention lip adaptedto retain a single staple from the supply of staples during a herniasurgery. In some forms, the pusher plate includes a chamfered portionadapted to engage only the single staple from the magazine of staples.In other forms, the pusher plate includes a cantilevered portion adaptedto engage and remove the single staple from the supply of staples. Thestapler can include an anvil plate positioned in the discharge headadjacent the pusher plate wherein the anvil plate has a step with aheight that corresponds to about the thickness of the single staple andthe step is adapted to position the single staple under the chamferedportion when the pusher plate passes over the anvil plate. Further, inone form, the elongated shaft includes a first tab and a second tab, theanvil plate defines a first keyway and a second keyway, and the firstand second tabs are adapted to engage and retain the first and secondkeyways, respectively, when the anvil plate is assembled with theelongated shaft.

Further forms, objects, features, aspects, benefits, advantages, andembodiments of the present invention will become apparent from adetailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view of an embodiment of the presentinvention.

FIG. 1A is an enlarged fragmentary view of a portion of the stapler headshowing a staple projecting from the staple exit port and showing thetip of a mesh positioning probe wire.

FIG. 2 is a front elevational view of the stapler.

FIG. 2A is an enlarged fragmentary front view of the stapler headportion.

FIG. 3 is an enlarged fragmentary schematic view of the stapler headportion with a probe wire type curved forward to push mesh to a desiredposition on body tissue for stapling.

FIG. 3A illustrates the actual use of the wire pushing a piece of meshforward.

FIG. 4 is a view similar to FIG. 3 but showing the probe wire tipportion angled backward to pull the mesh.

FIG. 4A is similar to FIG. 3A but showing the tip of FIG. 4 engaged topull the mesh.

FIG. 5 is a schematic view of a piece of mesh shaped for placement inthe repair site and illustrating the location where stapling is desired.

FIG. 6 is a schematic view of the repair site with stapler head in theopening.

FIG. 7 is a schematic view of the repair site with the stapler inposition for stapling the mesh to the underside of body tissue at thefar side of the opening.

FIG. 8A is a view of a staple before installation.

FIGS. 8B, 8C, 8D and 8E represent four possible different configurationsof the staple after stapling, the shapes being determined by stapleforming features specified for incorporation in the stapler head.

FIG. 9 is a schematic of the site and viewed in the direction of arrows9-9 in FIG. 7.

FIG. 10 is a side elevational view of a stapler of new construction.

FIG. 11 is an exploded view of the FIG. 10 stapler with the second halfof the handle omitted for clarity.

FIG. 12 is an underside view of the staple discharge head of the FIG. 10stapler with the front wall piece 152 and the supporting magazine 140for the staples removed for clarity.

FIG. 13 is the underside view of FIG. 12 with a staple partially formed.

FIG. 14A is an end view of the discharge head of the FIG. 10 stapler,viewed in the direction of arrows 14-14 in FIG. 10.

FIGS. 14B-D are views of alternative arrangements for the prongs on thedischarge head.

FIG. 15 is an underside view of another embodiment of a staple dischargehead with a front wall piece and a supporting magazine for staplesremoved for clarity in an initial position.

FIG. 16 is the underside view of the FIG. 15 embodiment with one staplestripped from a stack of staples wherein the single staple is resting ona step on a back wall plate.

FIG. 17 is the underside view of the FIG. 15 embodiment with the singlestaple adjacent the step on the back wall plate.

FIG. 18 is the underside view of the FIG. 15 embodiment with the singlestaple in contact with the anvils.

FIG. 19 is the underside view of the FIG. 15 embodiment with the singlestaple partially deformed around the anvils.

FIG. 20 is the underside view of the FIG. 15 embodiment with the singlestaple fully formed around the anvils.

FIG. 21 is a partial view of the FIG. 20 embodiment.

FIG. 22 is a top view of the backwall and base from FIG. 15 embodiment.

FIG. 23 is a partially assembled view of the FIG. 22 embodiment.

FIG. 24 is a fully assembled view of the FIG. 22 embodiment.

FIG. 25 is a side elevational view of another embodiment of a stapler.

FIG. 26 is a side elevational view of an elongated shaft of the FIG. 25embodiment.

FIG. 27 is a top elevational view of the FIG. 26 embodiment.

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purpose of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended. Any alterations and further modificationsin the described embodiments, and any further applications of theprinciples of the invention as described herein are contemplated aswould normally occur to one skilled in the art to which the inventionrelates. One embodiment of the invention is shown in great detail,although it will be apparent to those skilled in the relevant art thatsome features that are not relevant to the present invention may not beshown for the sake of clarity.

Referring to FIGS. 1-2A, a stapler 11 has a handle 12 with a trigger 13pivotally mounted to the handle at 14. A shaft or tube 16 is fixed tothe handle and has a stapler head portion 17 at its distal end. The headportion turns downward at an angle of about forty degrees (A in FIG. 1)from an axis 18 and has a staple discharge port 19 through which staplesare shot, one staple for each trigger pull. The trigger coupling to thestaple shooter is a two-stage system whereby a staple 21 can be advancedfrom within the head to a position shown in FIGS. 1 and 1A. Then, uponfurther pull of the trigger it can be shot through the mesh into thetissue.

One inventive feature is the provision of a mesh manipulator near theoutlet port of the stapler. As used herein, a “mesh manipulator” doesnot include the staple itself, but rather it is a structure other thanthe staple that is operable to be used to manipulate surgical mesh. InFIGS. 1 and 1A, the mesh manipulator comprises an elongated member orwire 22 having a distal portion including a tip 23 which projectsdownward under the stapler head portion 17 in the plane 25 (FIG. 2A)containing the axis 18 of the tube 16 and bisecting the handle 12. Thiselongated member extends from the tip portion backward through a channel24 at the bottom of the tube 16. A wire control button 26 slidable onthe channel and connected to the proximal end of the wire is provided toslide the wire forward to extend the tip 23 farther below the stapledischarge port 19, or retract it into the channel 24 when and to whatextent desired by the surgeon. Other locations for the wire controlbutton 26 can be used when and desired by the user. One example is inthe handle itself.

For purposes of useful mesh manipulation, the wire 22 would often, butnot always, be positioned such that the tip 23 projects severalmillimeters beyond the plane 40 defined by the discharge port 19, asshown in FIG. 1A. For example, it is expected that useful meshmanipulation can be achieved when the tip 23 is at least about 2 mm, 3mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm distal to plane 40.

Referring now to FIGS. 3 and 3A, a wire 27 is provided with a curved tipportion 28 curved downward and forward for insertion through a mesh 29and pushing it forward in the direction of arrow 31 to move it to theposition desired for stapling. This forward movement may be made bymoving the stapler itself using the handle or by moving the wire bymoving the wire control button 26.

Referring to FIGS. 4 and 4A, a wire 32 has a tip portion 33 which iscurved rearward to enable the wire tip to pass through the mesh 29 andpull it rearward in the direction of arrow 34 to position the mesh wheredesired relative to the location at which the stapling through the meshto the tissue is desired.

Referring now to FIG. 5, there is a schematic showing the mesh 29 cutfrom a sheet into a shape desired for placement at the surgery site.There are shown eleven sites at the edges of the mesh indicating wherestapling inboard from the edges is desired. This is an example, asdifferent sizes and shapes and numbers of staples may be chosendepending upon the requirements of the site.

FIG. 6 is a schematic illustration of the site with the staple headinserted into an opening 36. Consider that an opening edge 37 nearestthe surgeon is referred to in this context, as the near edge, and anopposite edge 38 is the far edge. Attachment of the mesh to tissue belowthe near edge 37 by stapling can be relatively straight forward with thestapler oriented as shown in FIG. 6, but pulled outward to place thehead at the near edge 37 and move the head downward to the mesh andshoot the staple down into the mesh with the prongs into the tissuebelow. On the opposite edge, the mesh is to be stapled to the upperinside face of the tissue. That is extremely difficult with conventionalinstruments. The present invention is capable of being turned upsidedown as shown in FIGS. 7 and 9 so that the discharge port 19 and tip 23are facing upwardly to the tissue and pushed or pulled by a wire tipsuch as shown in FIG. 3 or FIG. 4, depending upon the most effectiveapproach to push or pull the mesh to the location desired for staplingand then fire the staple upward with the prongs through the mesh andinto inverted or lofted tissue.

In FIG. 1, for example and without limitation, the stapler head portion17 has the discharge port angled down as shown at A. As an example, thisangle can be between 30 and 50 degrees from the center line 18 of theshaft. In one example, 45 degrees might be the optimal angle.

The total offset B between the bottom of the head and top of the shaftis preferably between 12 and 25 mm. Other angles and offset dimensionsmay be used if desired or necessary to the particular surgical site. Theoverall length between the head and the proximal end of tube 16 at itsentrance to the handle 12 may be 85 mm, for example. Again, otherdimensions may be determined according to the preference of the surgeonand the nature of the surgical site. The same is true as to the shapeand nature of the handle, one example of a different shape isillustrated in FIGS. 10-11 as will be described. The width of the staplebetween the prongs may be 5 mm, for example, but staples of other widthsmight be selected for particular cases. For example, it may be desirableto produce a fully formed box staple using 0.5 mm staple wire whereinthe formed staple has a width of about 7.5 mm and a height of about 3.5mm. In some tools, it might be considered desirable to make the shaftrotatable in the handle and/or to provide an articulation joint in theshaft near where it enters the handle, but, for the present, it appearsthat simply inverting the handle from the attitude as shown in FIG. 1 tothat as shown in FIGS. 7 and 9 would appear to be adequate. A variety ofmechanisms for discharging a staple can be implemented. For example,U.S. Pat. No. 5,829,662 and U.S. Pat. No. 5,743,456 describe endoscopicstapling equipment that could be adapted to implement the presentinvention.

Referring now to FIGS. 10-14A, stapler 100 comprises a handle unit 120and a downwardly disposed discharge head 130 at either end of anelongated shaft 110. A staple stack or magazine 140 containing a supplyof staples (e.g. 15) is mounted to the underside of the shaft 110.Trigger 122 is operative to cause a staple 160 to be formed anddischarged from an outlet port 162 of head 130. Successive pulls of thetrigger form and discharge successive staples from the magazine 140, anda running staple count is displayed in a window at 170.

Formation and discharge of a staple is accomplished via a single strokeof pusher plate 116, which is coupled to trigger 122 via a mechanicallinkage that extends through the shaft 110. More specifically, driveblock 125 is mounted in a slot in housing 123 with one end ofcompression spring 127 over tab 126 and the other end against tab 124.The drive block 125 is coupled to a driver 113 or rigid bar, which isslidably disposed in the channel of shaft 110 defined between the uppercover 111 and base 114. A stiffener 112 is also provided in the shaftchannel to increase structural rigidity of the elongated straightportion of the shaft 110. A flexible pusher 115 is coupled to the end ofdriver 113 and traverses the curved portion of the shaft channel, whichincludes support ribs for flexible pusher 115 in the upper cover 111 toreduce the possibility that the flexible pusher 115 would buckle orotherwise deform. Pusher plate 116 is laminated to the distal end offlexible pusher 115 for a seamless connection. Other connections arepossible as well.

In operation, squeezing the trigger 122 drives block 125 to the right(FIGS. 10, 11), overcoming the restoring forces of springs 127, 128.Springs 127, 128 each function as a return spring, thereby providingredundancy, but their spring parameters may be selected to produce adesired effect (e.g. substantially increased return force at maximumtrigger depression). As block 125 travels right, a one-way clutchassembly 129 engages cogs (not shown) on the underside of block 125 toprevent retraction of block 125 short of a full stroke. In addition,shuttle plate 176 is carried above block 125 and operates to advancenumbered ribbon 172, which is sandwiched between shuttle plate 176 andstay plate 174 and provides a running count of staples via a windowadjacent backing plate 170.

At the beginning of a stroke, pusher plate 116 is withdrawn into thedischarge head 130, and the first staple in the magazine 140 is advancedinto the firing breech. As shown in FIGS. 12 and 13, the staples in themagazine 140 are in the form of an angled stack, with each staple 160 inthe stack oriented in its firing direction (i.e. parallel to thebackwall 132 of the breech) and the axis of the stack 40-50 degrees fromorthogonal to the firing direction.

As illustrated, the staples in the magazine are generally “M” shaped andare mounted over the front rails of a holder 144, with each hump overone of the rails. A cover plate 143 is secured to the top of holder 144and a spring pusher 145 biases the staple stack 140 towards the open,angled end of the holder 144. As illustrated, the spring biasing pusher145 has an uncompressed length greater than the length of the staplestack, which can serve to provide a more constant force on the staplestack as staples are discharged. Guide 146 is positioned at the open endof holder 144 and provides angled fingers that prevent the staples fromdropping out the angled, open end prematurely. The staple magazine 140is mounted to supporting rails on base 114 and covered by a protectiveshroud 142, and front wall piece 152 is secured to complete theassembly.

As it advances in its stroke, the forming fingers 135 of pusher plate116 pick off the first staple from the stack and form the staple aroundanvil 133. FIG. 13 illustrates a partially formed staple extending fromoutlet port 162. Continuation of the forming fingers 135 serves to fullyform the staple into a desired box like shape, and preferably with thestaple prongs inverted slightly rearward. Retraction of forming fingers135 releases the leaf springs 134, which had been displaced on thedownstroke, which serves to displace the now-formed staple from anvil133. Because the formed staple is narrower, it slips readily through thewider central opening of outlet port 162, as shown in FIGS. 14A-D.

As illustrated, stapler 100 includes fixed prongs 150 on the undersideoutside of outlet port 162. Prongs 150 serve as mesh manipulators andmay be used in any fashion contemplated herein. FIGS. 14B-D provideillustrations of additional or alternative locations for meshmanipulating prongs about the staple discharge port. Fixed prongs canalso be used in combination with a retractable wire to provide furthercombinations of manipulating capabilities.

It is also contemplated that stapler 100 can be used without any meansfor mesh manipulation.

Numerous variations of the staplers described herein can be employed.For example, it may be desirable to provide one or more points ofarticulation along the shaft of the staplers described. As one example,a joint capable of 90 degrees articulation can be along shaft 110, forexample near where shaft 110 and handle 120 meet. The provision of suchan articulation joint may make it easier for the right handed surgeon,when operating on a right inguinal hernia, to place the staples thatattach the mesh to the inguinal ligament.

Staples used herein can be absorbable or non absorbable with materialinside the absorbable material for forming the staple and can be squareshaped, round shaped, G shaped, etc. The staples can be stacked togetheralong a rack inside the shaft that guides the staples to the distal endof the shaft with a spring loaded action, or a mechanism in the handle.

Procedures

Either under local anesthesia with sedation or general anesthesia, thelower abdomen is prepped and draped. A linear 6 to 8 cm skin incision ismade along the natural skin lines. Hemostasis is obtained. The externaloblique aponeurosis is divided, exposing the spermatic cord. Dependingon what type of hernia, the hernia sac is dissected from adjacenttissues, emptied of any contents and pushed back into the peritonealcavity. The mesh to be used is cut to its standard shape and size, and atail slit is placed to accommodate the spermatic cord. The stapler isthen used to fix the mesh to the insertion of the rectus sheath andalong the inguinal ligament. More specifically, the stapler is used tofix the mesh to the rectus sheath, above its insertion to the pubicbone. (The stapler is sized and shaped to assure the safety of thefemoral vessels and nerve.) The upper edge of the mesh is stapled to therectus sheath and the internal oblique aponeurosis avoiding theiliohypogastric nerve. Either a staple or a single non-absorbable sutureis then placed through the lower edges of the tails at the level of theinternal ring. The wound is then closed in layers after all bleeding hasbeen stopped and the sponge and instrument count is correct. The wound(i.e. the skin) can be closed with the stapler or with a conventionalsuture.

It is to be appreciated that what has been described includes animproved surgical stapler for attaching surgical mesh, comprising anelongated shaft having a handle at its proximal end and a downwardlydisposed staple discharge port at its distal end, wherein the handle isoperable to cause a supply of staples to be selectively discharged fromthe port; and one or more mesh manipulators near the port and projectingdistal to the plane defined by the port.

What has also been described includes an apparatus for use by a personstapling mesh to body tissue at a site of inguinal hernia surgery andcomprising: a handle for holding the apparatus adjacent the surgerysite, and having a proximal end and a distal end; a shaft defining alongitudinal axis and having a proximal end and a distal end and havingthe proximal end mounted to the distal end of the handle; a stapledischarge head having one end with a mounting portion connected to thedistal end of the shaft, and having another end with a staple exit port;the head adapted to fire a staple out from said head through said portalong a line and in a direction away from the handle, wherein thedirection of staple firing is downward relative to the longitudinal axisof the shaft; an elongated member mounted to said shaft and extendinggenerally parallel to the shaft and in a direction forward away fromsaid handle, the member having a distal end portion in a planecontaining the direction of staple firing, and the distal end portion ofsaid member being spaced from said line and under the line; and thedistal end portion of said member having a tip configured to engage amesh useful for embedding in a body cavity during inguinal herniasurgery, for connecting and moving said mesh to a location for staplingthe mesh to body tissue at the surgery site. In one refinement, thedistal end portion of said member is straight and curves downward andthen forward in said plane to said tip. In another refinement, thedistal end portion of said member is straight and curves downward andthen rearward in the plane to the tip. In another refinement, a guide onthe shaft receives the elongated member and has a proximal end near thehandle and a distal end opening exposing the distal end portion of thewire forward of the distal end opening of said guide, and confining theelongated member from the distal end portion of the member rearward to alocation adjacent the handle. It may further include a manipulator onthe elongated member adjacent the handle for alternately advancing andretracting the tip of the member.

What is also described is an apparatus for use in stapling mesh to bodytissue at a site of inguinal hernia repair surgery and comprising: ashaft having a proximal end and a distal end; a staple discharging headat the distal end of the shaft; a staple inside the head, the staplehaving a generally U-shaped configuration with spaced prongs in a firstplane; and a discharge port on the head for discharge of said stapleoutward from said head through the discharge port; and a meshmanipulator connected to the head and having a tip adjacent the portwherein the tip of the manipulator is spaced from said first plane ashort distance to avoid contact by the staple when discharged outwardfrom the port into the mesh.

What is also described includes, during inguinal hernia repair, a methodof attaching a mesh covering herniated membrane, to body tissue adjacentand bordering the site of the herniation, and comprising: inserting thehead of a stapling apparatus into an opening bordered by said tissue anddirecting a staple discharge port downward toward said mesh at a nearside of said opening and firing staples from said port through said meshinto some of said tissue adjacent said herniation, at multiple locationson the near side of said opening; and moving the head of a staplingapparatus in an opening bordered by said tissue and directing a stapledischarge port upward toward said mesh at a far side of said opening andfiring staples from said port through said mesh into some of saidtissue, at multiple locations on the far side of said opening. Themethod may further include engaging said mesh with a probe point mountedto said head and located between said port and said mesh, and movingsaid mesh with said probe to position said mesh at a location on saidtissue where a staple is to be fired into said mesh and said tissue. Themethod may further include moving said mesh by pushing said mesh withsaid probe point and/or pulling said mesh with said probe point. Pullingthe mesh may be used to lift said mesh on said far side. The mesh may bepierced to facilitate said moving of said mesh.

Another embodiment of a stapler 200 is illustrated in FIGS. 15-27. It isto be appreciated, stapler 200 is similar to stapler 100 in manyaspects; therefore, for the sake of brevity similar features will not bediscussed. As illustrated in FIG. 25, stapler 200 includes a handle unit220 and a downwardly disposed discharge head 230 at the distal end of anelongated shaft 210. A staple magazine 240 containing a supply ofstaples is mounted to the underside of the elongated shaft 210. Trigger222 is operative to cause a staple 260 to be formed and discharged froman outlet port 251 of the discharge head 230. Successive pulls of thetrigger 222 form and discharge successive staples from magazine 240, anda running staple count is displayed in a window 271. Stapler 200 alsoincludes a pair of fixed prongs 250 near the outlet port 251. Prongs 250are similar to prongs 150; therefore, prongs 250 serve as meshmanipulators and may be used in any fashion contemplated herein. It isalso contemplated that stapler 200 can be used without any means formesh manipulation, such as prongs 250.

Similar to stapler 100, formation and discharge of a staple isaccomplished via a single stroke of a pusher plate 216, which is coupledto the trigger 222 via a mechanical linkage that extends through theelongated shaft 210. The mechanical linkage in the embodimentillustrated in FIGS. 15-27 is similar to the mechanical linkagedescribed above and illustrated in FIGS. 10-14A. A flexible pusher 215is coupled to the end of a driver (not shown) and traverses the curvedportion of the channel of the elongated shaft 210. Pusher plate 216 isattached to the distal end of flexible pusher 215.

Pusher plate 216 includes a pair of forming fingers 235 that are similarto forming fingers 135; however, each of forming fingers 235 asillustrated in FIG. 21 includes a chamfered portion 238, a cantileveredportion 248, and a retention lip 258. The chamfered portion 238, thecantilevered portion 248, and the retention lip 258 facilitate pickingoff a single staple 260 from the supply of staples. The chamferedportion 238 and cantilevered portion 248 pick off a single staple 260 asthe pusher plate 216 passes under the stack of staples. As such, thechamfered portion 238 and cantilevered portion 248 do not engage theproximal staple surface to move another staple distally in the stack ofstaples. Therefore, the stack of staples remains undisturbed. In someapplications, the use of fixed prongs 250 to hold mesh during a medicalprocedure may cause side loads or forces that are applied to the staplethereby resulting in tension on the staple and incomplete stapleformation. These side loads or forces are out of the plane of thestapler 200 and can cause the staple to slip off the forming fingers235. However, the cantilevered portion 248 and the retention lip 258retain the staple between forming fingers 235. The retention lip 258engages the top of the staple 260 during formation of the staple 260 torestrain the staple 260 from forces caused by prongs 250 on the mesh asthe staple 260 is attached to body tissue. The cantilevered portion 248helps to retain the staple 260 from slipping or twisting away from theretention lip 258. Each of the forming fingers 235 includes an inneredge 252, an outer edge 254, and a staple contact portion 239 that spansbetween the inner edge 252 and the outer edge 254. The inner edge 252includes the chamfered portion 238. The inner edge 252 and the staplecontact portion 239 include the cantilevered portion 248 and theretention lip 258. Between the pair of forming fingers 235 is positioneda wider portion 256 that is substantially perpendicular to the inneredge 252.

The channel of the elongated shaft 210 is defined between an upper cover211 and a base 214. The base 214 includes a first key or tab 300positioned on a first edge 302 and a second key or tab 304 positioned ona second edge 306 as illustrated in FIGS. 22, 23, and 24. The base 214also defines a first opening 308 adjacent the first key 300 on the firstedge 302. The base 214 also defines a second opening 309 adjacent thesecond key 304 along the second edge 306. The first key 300 and thesecond key 304 are sized and configured to interact and engage a firstkeyway 310 and a second keyway 312, respectively, on a backwall or anvilplate 232. Further, the first opening 308 is sized to receive the firstkeyway 310. Correspondingly, the second opening 309 is sized to receivethe second keyway 312. As the backwall 232 is assembled with the base214, the first keyway 310 is positioned and inserted in the firstopening 308 and the second keyway 312 is positioned and inserted in thesecond opening 309 as illustrated in FIG. 23. Thereafter, the backwall232 is slid or pushed toward the distal end of the elongated shaft 210to engage the first keyway 310 with the first key 300 and the secondkeyway 312 with the second key 304. The first key 300 engages andretains the first keyway 310 and the second key 304 engages and retainsthe second keyway 312. The connection between the first key 300 and thefirst keyway 310 and the connection between the second key 304 and thesecond keyway 312 provides a mechanical interaction between the backwall232 and the base 214. As such, adhesive is not required to attach thebackwall 232 with the base 214. In other embodiments, adhesive may beused, if desired, to attach the backwall 232 with the base 214.

The backwall or anvil plate 232 includes a top face 272 and an oppositebottom face 270. The top face 272 is positioned to face or interact withthe supply of staples when the backwall 232 is assembled with the base214 of elongated shaft 210. The top face 272 includes a step or plateau274 that has a thickness that corresponds to about the thickness (orless) of a single staple. The step 274 functions as an elevated staplestaging area for the supply of staples. The width of step 274 is aboutthe same as wider portion 256 of pusher plate 216. As such, the formingfingers 235 of pusher plate 216 slide next to the step 274 as thechamfered portion 238, the cantilevered portion 248, and the retentionlip 258 pick off a single staple and advance that staple toward a pairof anvils 276 as described in more detail below. The top face 272 alsoincludes a lower portion 275 that is positioned between the step 274 anda pair of anvils 276. Similar to backwall 132, backwall 232 includes apair of anvils 276 around which the staple 260 is formed. The uppermoststaple from the supply of staples rests against the step 274 such that acenter portion of the staple contacts the step 274 while the outer legsof the staple rest against lower portion 275 thereby causing the stapleto rotate slightly. As such, the center portion of the staple iselevated above the legs of the staple as shown in FIG. 15. As the stapleis pushed by the forming fingers 235, the staple passes over the step274 and drops onto the lower portion 275 such that the staple isretained in the retention lip 258. The remainder of the pusher plate 216passes over the step 274 as the staple engages the anvils 276. Moreover,the step 274 and pusher plate 216 each have a thickness that enables thechamfered portion 238 to pass under a second staple in the stack ofstaples (as shown in FIGS. 15 and 16) and engage only the staple restingon step 274 to ensure pickoff of only one staple.

The staple contact portion 239 is beveled to further facilitate theforming fingers 235 engagement of a single staple. The staple contactportion 239 does not disturb the adjacent staple and helps to eliminatestaple jamming. The chamfered portion 238, staple contact portion 239,cantilevered portion 248, and retention lip 258 on pusher plate 216 andthe step 274 on backwall 232 work together to ensure that only a singlestaple 260 from the supply of staples is ejected at deployment.

The base 214 also includes a first rail 322 and an opposite second rail326 as shown in FIGS. 26 and 27. In the illustrated embodiment, thefirst rail 322 includes a first plurality of energy directors 328 andthe second rail 326 includes a second plurality of energy directors 330.The first and second plurality of energy directors 328 and 330 each havea wedge or rectangular shape; however, the energy directors 328 and 330can be shaped differently in other embodiments. The base 214 alsoincludes a first distal rail 332 along the first edge 302. The base 214also includes a second distal rail 336 along the second edge 306. Thefirst and second distal rails 332 and 336 include a first plurality ofenergy directors 338 and a second plurality of energy directors 340,respectively. To join the base 214 with the staple magazine 240, a coverplate (not illustrated) of the staple magazine 240 is positioned next tothe base 214. Next, ultrasonic welding equipment is used to provideultrasonic energy to melt the plurality of energy directors 328, 330,338, and 340 to create a joint between the base 214 and the cover plate.Other embodiments may use different techniques to attach the staplemagazine 240 to the base 214. Some examples include adhesive, snap-fitconnections, or other mechanical type connections.

In operation, the trigger 222 is squeezed which drives the block (notillustrated but similar to block 125) to the left in FIG. 25. At thebeginning of a stroke, pusher plate 216 is withdrawn into the dischargehead 230, and the first staple in the magazine 240 is advanced into thefiring breech. The staples in magazine 240 are similar to the staples inmagazine 140. As pusher plate 216 advances in its stroke, the formingfingers 235 contact and pick off the first staple from the stack asillustrated in FIG. 16. In particular, the cantilevered portion 248 onthe staple contact portion 239 engages the staple 260 and pushes thestaple 260 towards the pair of anvils 276 as the pusher plate 216continues to advance. Also, the cantilevered portion 248 on the staplecontact portion 239 and the chamfered portion 238 of the pusher plate216 clear or pass under the staple that is adjacent to staple 260 in thestack of staples. As such, the remaining staples are generallyundisturbed during deployment. Next, as the pusher plate 216 advancesforward, the staple 260 moves off the step 274 and onto the lowerportion 275 such that the retention lip 258 engages the top of thestaple 260 as illustrated in FIG. 17. As the pusher plate 216 continuesto advance forward, the staple 260 contacts the pair of anvils 276 asillustrated in FIG. 18. Thereafter, as illustrated in FIG. 19, chamferedportion 238 and retention lip 258 continue to engage and retain thestaple 260 adjacent the pair of anvils 276 and fully form the staple 260into a desired box like shape, and preferably with the staple prongsinverted slightly rearward as illustrated in FIG. 20. Therefore, ifforce is applied to the staple 260, the cantilevered portion 248 assiststo retain the staple 260 on the retention lip 258. Retraction of thepusher plate 216 releases leaf springs (not illustrated) which had beendisplaced on the down stroke, which serves to displace the now-formedstaple 260 from the pair of anvils 276.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges, equivalents, and modifications that come within the spirit ofthe inventions defined by following claims are desired to be protected.All publications, patents, and patent applications cited in thisspecification are herein incorporated by reference as if each individualpublication, patent, or patent application were specifically andindividually indicated to be incorporated by reference and set forth inits entirety herein.

1. A method of attaching a surgical mesh comprising: providing asurgical stapler having an elongated shaft with a handle at its proximalend and a downwardly disposed staple discharge head at its distal end,wherein the handle is operable to cause a supply of staples to beselectively discharged from the head, the surgical stapler having one ormore mesh manipulators near the staple discharge head; using the meshmanipulator to position the mesh; and using the stapler to attach themesh to tissue.
 2. The method of claim 1 wherein the tissue is theinguinal ligament.
 3. The method of claim 1 wherein the mesh manipulatorcomprises one or more prongs extending from the discharge head of thestapler.
 4. The method of claim 1 wherein the mesh manipulator comprisesa wire.
 5. The method of claim 1 further comprising: retaining a singlestaple from the supply of staples between a pair of forming fingers on apusher plate disposed in the staple discharge head.
 6. The method ofclaim 5 further comprising: an anvil plate positioned in the dischargehead adjacent the pusher plate, the anvil plate having a step with aheight that corresponds to about the thickness of the single staple;pushing the pusher plate over the anvil plate; and positioning thesingle staple under the chamfered portion as the pusher plate passesover the anvil plate.
 7. The method of claim 6 further comprising:rotating the single staple away from the supply of staples as the pusherplate passes over the anvil plate.
 8. During inguinal hernia repair, amethod of attaching a mesh covering a herniated membrane to body tissueadjacent and bordering the site of the herniation, the methodcomprising: inserting a staple discharge head of a stapling apparatusinto an opening bordered by said tissue and directing the stapledischarge head downward toward said mesh at a near side of said openingand firing staples from the staple discharge head through said mesh intosome of said tissue adjacent said herniation, at multiple locations onthe near side of said opening; moving the head of the stapling apparatusin an opening bordered by said tissue; and directing the stapledischarge head upward toward said mesh at a far side of said opening andfiring staples from the head through said mesh into some of said tissue,at multiple locations on the far side of said opening.
 9. The method ofclaim 8 further comprising: engaging said mesh with one or more meshmanipulating members mounted to said head; and moving said mesh withsaid probe to position said mesh at a location on said tissue where astaple is to be fired into said mesh and said tissue.
 10. The method ofclaim 8 wherein the mesh manipulating members comprise a plurality ofprongs extending from said head.
 11. The method of claim 8 furthercomprising: the stapling apparatus having a pusher plate positioned inthe staple discharge head, the pusher plate including a retention lipadapted to retain a single staple, wherein the pusher plate includes achamfered portion adapted to engage only the single staple, the staplingapparatus also having an anvil plate positioned in the staple dischargehead adjacent the pusher plate, the anvil plate having a step with aheight of about the thickness of the single staple; moving the pusherplate over the anvil plate; and retaining the single staple under thechamfered portion of the pusher plate.
 12. The method of claim 11further comprising: rotating the single staple away from the supply ofstaples as the pusher plate moves over the anvil plate.